H4: device manufactured between january 24, 2020 to january 25, 2020.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed which revealed a leak in the front side of the bag approximately at the 1600 ml fixed print scale area.Upon magnified inspection verified a small tear/hole in front of the bag where the leak occurred.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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